An observational study in Pertussis (Whooping Cough), Tetanus and Diphtheria, sponsored by BioNet-Asia Co., Ltd.. Completed at 1 site in Thailand. Open to participants aged 3 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by BioNet-Asia Co., Ltd. · Observational
This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.
Doctors, nurses, and other healthcare professionals from hospitals and clinics in central, eastern, southern, and northern Thailand take part in the study. They report any health problems that occur after vaccination using standard reporting forms.
The information collected helps researchers understand how safe the vaccine is when used in a large and diverse population under real-world conditions.
Primary objective: To describe the post-licensure safety profile of Boostagen® in Thailand.
Secondary objective: To identify any unexpected safety signals following vaccination with Boostagen®.
HCPs eligible to participate were those who prescribed or administered Boostagen®. as a booster immunization in line with national guidelines. Recruitment was carried out in hospitals and clinics located in central, eastern, southern and northern Thailand. HCPs who agreed to participate were interviewed periodically regarding adverse events following immunization (AEFIs) with Boostagen®.
Data collection was performed using a standardized questionnaire administered monthly, either in person or by telephone. The questionnaire captured the number and type of AEFIs observed, along with other safety-related information.
HCPs used a modified WHO AEFI report form to document adverse events. In addition, a pregnancy safety outcome report form was developed to collect data on pregnancy outcomes among vaccinated pregnant women and their newborn. This structured approach enabled systematic monitoring's safety profile in real-world conditions and ensured early identification of any unexpected safety signals.
Statistical Analysis. No formal prespecified study hypothesis was established. Descriptive statistical methods were applied to summarize demographic and baseline characteristics of Boostagen® recipients, including children, adolescents, adults, and pregnant women. The incidence rates and proportions of AEFIs were calculated. For pregnant women vaccinated with Boostagen®, pregnancy outcomes, pregnancy-related complications, and neonatal outcomes were summarized. Continuous variables were described using means and standard deviations, while categorical variables were presented as frequencies and percentages. Ninety-five percent confidence intervals (95% CIs) were calculated where appropriate. All statistical analyses were performed using SPSS software, version 18.0 (SPSS Inc., Chicago, IL, USA).
290 studies on the registry are indexed under Whooping Cough; 23 are open to participants now.
This study's enrollment of 10,727 is above the median of 510 across 60 observational studies indexed under Whooping Cough.
Browse Whooping Cough studies →BioNet-Asia Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of a cohort of HCPs working in private and government hospitals and clinics in central, eastern, northern and southern Thailand where Boostagen® vaccine is marketed. An HCP is defined as medically qualified person, such as physician, nurse or pharmacist.
Inclusion Criteria: An HCP will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
Exclusion Criteria:
Vaccinees consist of children, adolescents and adults including pregnant women in private and government hospitals and clinics located in the central, eastern, northern, and southern regions of Thailand.
Incidence and percentage of AEFIs following vaccination with Boostagen®
Measure the frequency, categorize the types, assess the severity, and determine the causal relationship to vaccination for all AEFIs.
Time frame: From the date of vaccination up to 30 days post-vaccination.
Incidence and percentage of pregnant women vaccinated with Boostagen® who had experienced complications during pregnancy
Incidence rate is defined as the number of maternal complications in 1000 vaccinees. Pregnancy complications include but are not limited to the following: pregnancy loss or stillbirth, preterm delivery (\< 37 weeks of gestation), premature rupture of membranes, pregnancy-induced hypertension, pre-eclampsia/eclampsia, intrauterine growth restriction (IUGR), obstetric hemorrhage, and gestational diabetes.
Time frame: From administration of Boostagen® during pregnancy until delivery
Incidence and percentage of healthy and not healthy infants born to mothers who received Boostagen® during pregnancy
Incidence rate is defined as the number of healthy and not healthy infants in 1000 infants born to mothers who received Boostagen® during pregnancy. This outcome assesses the health status of infants born to mothers who received Boostagen® during pregnancy. Infants will be classified at birth as healthy or not healthy based on clinical assessment and review of delivery and neonatal records. A healthy infant is defined as a live-born infant without any congenital anomalies, neonatal complications, or conditions requiring significant medical intervention at birth. A not healthy infant is defined as a live-born infant with at least one reported adverse neonatal outcome, including but not limited to congenital anomalies, preterm birth, low birth weight, neonatal intensive care unit (NICU) admission, or other clinically significant medical conditions identified at or shortly after birth.
Time frame: From maternal vaccination during pregnancy until birth of the infant
Incidence and percentage of unexpected serious adverse events (SAEs) following Boostagen vaccination.
Number and percentage of participants in each population group (children, adolescents and adults including pregnant women) experiencing unexpected SAEs after Boostagen® vaccination. Events will be identified through electronic health records and classified per CIOMS/WHO definitions of SAEs and safety signals, which include any serious medical occurrence that may indicate a new potential association requiring further evaluation.
Time frame: From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.
Incidence and percentage of rare adverse events following Boostagen® vaccination
Number and percentage of participants with medically confirmed rare adverse events (events too uncommon to be detected in pre - licensure trials). Rare adverse event is defined as event occurring with a frequency of ≥ 1/10,000 and \< 1/1,000).
Time frame: From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.
Incidence and percentage of new patterns of known adverse events
Number and percentage of participants presenting new patterns of adverse events already associated with pertussis containing vaccines (e.g., shifts in severity, timing, clustering). Safety signals include new aspects of known associations, per CIOMS/WHO definitions. Data will be analyzed using temporal clustering and disproportionality analysis to identify unexpected patterns following Boostagen® vaccination.
Time frame: From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.
Ran from Jun 2017 to primary completion in Mar 2023, 68 months.
Of 22 observational studies under Whooping Cough, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's 68 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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BioNet-Asia Co., Ltd.